1. technology and computing
2. software
3. databases

 How to get your Movicon 11
project FDA 21 CFR Part 11
ready
Document:
RAC-4105
Released:
29-04-2005
Updated:
06-03-2012
Rel. Movicon:
11.3 or later
Summary
Document’s Aim............................................................................................................ 5 Introduction .................................................................................................................. 5 CONTROL SYSTEM REQUIREMENTS .............................................................................. 6 Security ..................................................................................................................... 6 The electronic signature ........................................................................................... 7 General Concepts for supporting these regulations ..................................................... 8 Security ..................................................................................................................... 8 Digital Recording/Electronic Signatures ................................................................... 9 Validation and Documentation .............................................................................. 10 Other ....................................................................................................................... 11 Configuration Techniques ........................................................................................... 12 Security ................................................................................................................... 12 Passwords ............................................................................................................... 14 Windows Security Synchronization ........................................................................ 15 User Passwords....................................................................................................... 15 Command Access .................................................................................................... 16 Operating System Access ....................................................................................... 17 Biometric Systems .................................................................................................. 18 Recording data (Audit Trail or Tracing) .................................................................. 19 Audit Trail ............................................................................................................... 20 Audit Trail with Process Manager Validation ......................................................... 21 Alarm Acknowledgment Comment (Audit Trail) .................................................... 22 Electronic Records .................................................................................................. 23 Data Security .......................................................................................................... 23 Implementing CFR21 Part 11 with Movicon 11
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The 21 CFR Part 11. regulations .................................................................................. 25 Subpart A—General Provisions .............................................................................. 25 Subpart B—Electronic Records ............................................................................... 25 Subpart C— Electronic Signatures .......................................................................... 25 General Provisions .................................................................................................. 26 Electronic Records .................................................................................................. 29 Electronic Signatures .............................................................................................. 39 Implementing CFR21 Part 11 with Movicon 11
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Document’sAim
To briefly explain the DFA CFR21 Part 11 regulations. To describe the procedures
and actions to take along with helpful advice to make the applied project, based on
the Movicon 11 SCADA platform, perform in conformance with these regulations.
  This document has been written by Progea Srl to inform Movicon Developers about
its concepts and the best way to apply it with digital data recording functions and in
the “electronic signature” application as required by the FDA regulations. This
document has no legal value and is not liable in any way to Progea: it is the
client’s responsibility to verify that they have developed the application in
compliance with the above mentioned regulations along with any updates that may
have been made.
Introduction
The aim of the CFR21 Part 11 regulations, written up by the FDA (Food & Drug
Administration), is to obtain a legal equivalence between electronic documents
(digital records and electronic signatures) and traditional paper documents. This has
evolved due to the increasingly frequent use of automatic systems in managing
production processes in systems that operate under FDA approval. In order that
automation and control systems are realised in conformance with the CFR21 Part 11
regulations it is necessary that all recorded data is made referable to the operator in
charge (Electronic signature), furthermore certain regulations regarding any
precautions must be adapted to safeguard against forgery and mishandling of
electronically recorded data, or to allow easy identification of any misuses, whether
intentionally or unintentionally, of electronic devices which generate electronic
records. Many pharmaceutical industries have especially benefited from using
electronic records where untold amounts of paper documentation, archived over
many years of research, has been transferred into electronic records which not only
has reduced space but also precious time in acquiring and reviewing important
information before releasing medicine on the market for sale.
It is absolutely crucial that these types of industries have the devices with the
right protection mechanisms to safeguard against any intentional or unintentional
data errors in electronic format.
Electronic Records: All significant processed data on production quality and
regularity must be permanently recorded and not tampered with on the processor.
These documents, called records, must be prepared, dated and signed by a person
and again dated and signed for approval by the production manager or whoever is in
charge. These records must be stored for at least one year after the production
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batch’s expiry date. The owner of the signature is held legally responsible for any
errors that may occur. Electronic records may be composed with texts, graphics,
data, tables or any other information in digital format which is created, edited,
stored, filed, retrieved or distributed using a computer system. Electronic Signature: An electronic signature is a combination of symbols that can
be used, adopted or authorised by an individual as a legal equivalent of their own
handwritten signature.
CONTROLSYSTEMREQUIREMENTS
The Control Systems must be capable of acquiring the status and behaviour of the
process’s variables in realtime. The date and the product batch number must be
entered along with the electronic signature of the operator and an eventual signature
of approval from the process manager in the section relating to the product batch’s
working period. These procedures must be carried out without the threat of causing
errors and that signatures are always unique and referable to their owners. The
records must be filed in a save place and stored for an adequate time period. They
must also be protected against unauthorized access.
Security
There are usually two reasons why data is recorded in electronic format.
The first being when data always has to be printed and signed for approval (the so
called Hybrid solution: paper and electronic). In this case the file is to be considered
an electronic record: the main problem is to ensure that the file and its data contents
are not substituted or modified before being printed, identified, dated and signed.
However the electronic signature may not always be necessary when signed
manually. Therefore, for example, it is necessary that the data format is uneditable
and is individualized and automatically associated to a specific production batch or
line. Furthermore the original data file must be archived. This reason can be
conclude by saying that a hand written signature does not necessarily give authority
to an electronic record inadequately protected.
The second reason is to keep records filed in electronic format. Apart from
guaranteeing that the file and its data contents cannot be substituted or modified and
need a signature of approval, the electronic signature is also required. The data file
should include information on the production batch it refers to and the name of the
person who approved this data, being the person registered as logged on when data
approval took place. All the file’s contents should then be protected from any
unauthorized modifications.
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Theelectronicsignature
The electronic signature can be created with a combination of at least two items such
as an ID code and a password or a badge and a password etc., as required by the
CFR21 part 11. The ID – password must be guaranteed that it is unique to that
person with absolute certainty of identifying them. The ID code can be made public,
meaning that it can be shown on screen. Since the password may not always be
guaranteed as being unique to just one person, it is absolutely necessary that the ID
code be original and personal to each user. These rules should be followed:
1.
A set minimum password length
2.
Change password periodically
3.
Carry out procedures to avoid any attempts of meddling or unauthorized
access
4.
Record any attempts of unauthorized access
5.
The system administrator must not know the password of other users even
when assisting them when they have forgotten their password.
6.
User Groups can share the same password only for reading data where the
electronic signature is not required.
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GeneralConceptsforsupportingthese
regulations
The concepts described below define how to use Movicon to develop applied projects
with compatibility with the act and its regulations discussed in this document.
A list of the main concepts has been put together by Progea to give a clearer picture
on the indications explained henceforth and which are based on the understanding
that it remains the user’s responsibility to ensure that the application, developed with
Movicon, is compliant with these requirements.
Security

The Movicon project must be encrypted (Movicon uses a 128 bit encoding) so
that all the configurations and passwords used in the project are accessible from
the outside.

Movicon guarantees unique user password entries in the project. Each user
is identified in the project with a UserID, Password, printable Description or Name
(Electronic Signature). Movicon does not accept Users with the same electronic
signature name (unique identity control) of another individual. The names must
be made up with not less than 4 characters and not more than 64 characters.

To guarantee data integrity and safeguard against any tampering of data, the
Movicon application should be run as Service of the Windows Operating
Systems. This will require identification of users registered in the system’s
domain according to the security requirements stipulated in order to access the
operating system and its files. However, Windows Services may be differ
according to the operating system being used as explained in the paragraphs
below.

Movicon supports Windows XP/Vista/7 OS domain sharing so that the user
passwords, set up by the system administrator, can be used.

Users who manage the recording of data by using the Data Loggers must take
the right measures to prevent any unauthorized access, undesired modifications
and tampering to database records. The IMDB archives (InMemory DB) allow
users to manage encrypted historical log files or secure databases can be used,
such as Microsoft SQL Server or Oracle with the appropriate administering of
the Windows XP/Vista/7 operating system, which only permit the system
administrator or developer access to records.

To put an access limit on the developed application’s functions and controls, the
Movicon project must use the User Password Profile management correctly,
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which involves the entering of a Password, UserID, User Name and Access Level.
Movicon provides 1024 access levels and 16 areas.

Users must manage their passwords with great care and integrity. New users,
inserted by the administrator, can replace their password with a more personal
one on their next Log On.

All passwords can be set with an expiry time to make the user to issue a new
password periodically, which will contribute to increasing system security.

To fully comply with the regulations, the Auto LogOff (timeout of enabled
access) must be appropriately used in the Movicon password management in
order to prevent unauthorized access to the system after a certain period of user
inactivity.

To ensure validity and the correct entering of data, users must make sure that
the Movicon operating stations are allocated in safe places and that they are
accessible to authorized personnel only.

The Movicon AutoLogoff function must be used in systems in continuous use.

Movicon has tools and procedures that can be used for discouraging any
unauthorized access attempts and are the same as those used in the Windows
XP/Vista/7 operating system as required by the regulations. After the third failed
attempt to access, Movicon will purposely take longer to respond to the re-entry
of the password to discourage the intruder.

Any further attempts to violate the system (Upon the third unauthorized Log On
attempt) Movicon will display and record the event in the Historical Log in order
to safeguard against and control any further system violations.
DigitalRecording/ElectronicSignatures

Movicon returns the descriptive name of the registered user to identify and
individualize the active operator.

The applied program must be configured to record electronic signatures each
time a digital recording is carried out (creating a record in the database) as
required by the regulations. The user must execute LogOn in the project by
linking two combined data (UserID and Password), and the electronic
signature must be the genuine name of the user, the date, time and reason
for the recording. The Movicon Data Logger allows the recording of all
necessary data on the Database.

For reasons of legal responsibility relating to the Electronic Recording, the
operator must always be acknowledged every time data is recorded or when
accessing the system. The User’s ID is unique and belongs to that user only
in Movicon and no other individuals are allowed the same ID.
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
To satisfy the Electronic Recording requirements, the recording of events
must be configured appropriately by using the IMDB archives (InMemory DB)
where crypted historical log files can be managed or if ODBC archives, such
as the Microsoft SQL Server or Oracle, secure databases must be used
with the correct security management administered. Furthermore the user
must configure applications to acquire and record electronic signatures on
record of any operator undertaking actions. The user must also prevent any
data from being lost by configuring the application to execute backups of all
data recorded, or by using the Movicon redundancy functions. The user can
also eventually configure the system so that it uses the Data Logger resource
to record crypted data on IMDB or on relational ODBC database files. If
needed, new data files can be created with prefixed timeframes (eg. Every 4,
8 or 24 hours) by using the Basic Script functions.

The user can configure the system to copy recorded data in a safe and
secure location by using procedures appropriately written with Basic Script
codes. The Windows XP/Vista/7 OS security functions protect files and their
data from any unauthorized access. When multiple files are created the user
must control whether the right code is entered to prevent saturating free
space on the hard disk where the oldest files may need to be deleted.

The user may have to synchronize the system’s time in real time or to that of
another system’s (Microsoft or third parties) so that recorded data relate to
the true date and time, or they may have to manage data synchronization
between Client and Server so recording becomes coherent. Synchronization
of this type can be managed directly with the Windows XP/Vista/7 OS
functions or with the Basic Script codes for third party products.
ValidationandDocumentation

Some of the requirements stipulated in the regulations are not altogether
implemented in software applications. These Part 11 requirements can be
satisfied if the client validates their application to guarantee accuracy,
reliability and security when recording data, as well as the capacity to
prevent unauthorized editing, errors and data deletions. The Movicon users
must validate their application in order to comply with the FDA act. The
users can develop and/or execute the validation of programs and protocol
themselves or delegate this task to others. The validation must follow a
methodology established from system’s life cycle (SLC).

In order to meet the controls requested by the regulations in this act, the
client must adopt adequate procedures to verify the identity of the individuals
who have been assigned an electronic signature.

The client must enter and set up the operator and their operating
responsibilities executed under their electronic signature, to impede any
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forgeries or tampering of signatures or recordings, in compliance to the
regulations of this act.

The client must always be certain on the identity of the individual assigned
an electronic signature. Furthermore the client is held responsible that the
enrolled operator is fully aware of the regulations stipulated by the FDA
agency and that they intend to use their electronic signature as a substitution
and an equivalent of their own handwritten signature used on traditional
paper and, when necessary, produce certification of their true identity, being
legally binding to their handwritten signature, when under FDA inspection.

The client is responsible for producing documentation on system use or on
the application realized, on its distribution and updates, and also the details
on personnel training.
However, the client is not responsible for
documentation on the platforms being used (Movicon, Windows).
Other

All the data must be stored in a relational database, which fully meets the
necessary security requirements (ie. IMDB crypted data, SQL Server or
Ocracle with the relevant protection) and protected from any violation to or
tampering of the security functions belonging to the Win2000/XP/Vista OS.
Data must be filed and kept available for an adequate period of time
according to the operating requirements.

To further enforce the safeguard of data, project, images and recipes the
user should use a third party software type, which can guarantee version
maintenance and management (eg. Microsoft Source Safe can be used for
controlling the versions).
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ConfigurationTechniques
To get a Movicon 11 project 21CFR Part 11 ready, you need to configure it
appropriately so that it is compactable with the FDA validation criteria. The
necessary measures to take in doing this are indicated below:
Security


The project must be configured in its General Properties by selecting
“Cripted Project” and “Cripted Project Resources”. In this case all the
project’s XML information can be accessed by using a 128 bit encoding. To
prevent unauthorized system access, select all the project’s Execution
Properties which deny Operating System and Desktop access. The
following can be denied:
o
Windows Desktop
o
The Start button form the Windows’ Task bar
o
Windows Task Bar
o
Windows task Options
o
Windows Task Manager
o
Windows CTRL+ALT+DEL
o
Warning! Commencing with Windows Vista/7 Microsoft has
implemented securities which impede the "Ctrl+Alt+Del"
combo keys and the Windows “Start” button from being
disabled.
As an alternative, Movicon can be run as “Service” of the operating system,
as described in more detail ahead. When Movicon is run as service, it does
not manage the project’s properties that deny operating system access and
which are listed above.
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An illustration of the project’s properties window
Important! Commencing with Windows Vista/7 the use of the graphical interface for Windows Services will no longer be supported. Windows Vista/7 has increase security by keeping the running of services and user applications in separate sessions. This not only increases system service security but also impedes the user from interacting with the service’s user interface. Running Movicon as Windows Vista/7 service will therefore exclude the use of the graphical interface. This problem can be avoided by creating a “Client” project which will be launched in the Windows user interface and communicate in network with the “Server” project launched as Service enabling use of the Server user interface remote control mode. Implementing CFR21 Part 11 with Movicon 11
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Passwords

All the application commands that can be executed by operators to interact
on the process must be protected by passwords.

The password management must be enabled in the project’s User
Passwords resource Properties:

o
Project Protected with Password: the password will be
requested only for entering in “Development” mode
o
Enable Password Management: the passwords will be activated
according to the levels and access modalities to the preset
commands.
o
Enable Electronic Signature: the unique user Description of the
user whose name is to be used as an Electronic Signature will be
managed.
o
Auto Log Off: determines the time (sec.) for automatically
deactivating the active user after a period of inactivity.
o
Minimum Length (user name and password): set for default at
4 and 6 characters respectively, as suggested by the regulations.
Secondary parameters relating to the password management need to be set
according to the general properties illustrated below.
The project’s User Password Resource properties window.
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WindowsSecuritySynchronization
Movicon provides the possibility to share, in applied applications, users from the
operating system domain or from a Windows XP/Vista/7 server.
Therefore, when activating the password management, the project will acknowledge
and accept users inserted and activated from the domain of the installed operating or
from a server station.
Movicon accepts mixed configurations, whether being users inserted on the project
list, or users deriving from the XP/Vista/7 domain.
Users on the project list can be associated with a customized user level. Users
deriving from a XP/Vista/7 station domain can receive a customized user level when
inserted on the user list, otherwise they will be associated the same password level
specified for the group they belong to (Administrators, Users, Guests).
Different password levels can be assigned to domain users. This function is made
available by adding users to the Movicon user list who have the same UserID
configured in the primary domain controller. Password authentication and validity are
carried out by the primary domain controller for those users configured in this way.
For instance if a user with UserID = “guest” exists in the primary domain controller, a
user can be configured with the same UserID, in this case “guest”, and the password
can be left blank in the Movicon project’s user list. By doing this the user can be
assigned the appropriated level desired. In runtime, the user’s name and password,
which are inserted in the Movicon user authentication window for logging on, are
validated by the primary domain controller. This permits expiry passwords to also be
used for Windows users.
This feature is also valid for users configured directly in runtime with the Movicon edit
users window.
UserPasswords

Each user or user group who has access to commands or process interaction,
must be inserted and configured in the project appropriately.

Users are inserted in the project’s User Password Resource where they
can be configured in their properties. These properties include those which
involve the requirements stipulated in the FDA act:
o
Name (ID) and Password. These are assigned to the user and are
used for identification by the system.
o
Electronic Signature: This is a unique text which corresponds to
the user’s electronic signature and is recorded as absolute user
identification (the Electronic Signature management must be enabled
in the User Password Resource)
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o
Auto Log Off: This can be specified singularly for each individual
user.
o
Expiring Password: The act stipulates that the user password
expires after a certain preset time so that the user is obliged to
change it periodically to increase system security.
o
Must Change Password: For identification certainty this obliges
the user to enter their own personal password on the next Log On so
it is only known to themselves and no one else including the
administrator who logged them on the first time.
This is a user properties window.
CommandAccess

Each command, change or setting influencing the process must be given
protected access by requesting user identification.

The User Level in a hierarchical scale structure must be set in the “Access
Level” property of each object. The Levels in Movicon start from 1023
(reserved for the system administrator) to level 1 (the lowest operating
level). The 1024 level is reserved for the programmer.

The command objects can also be provided with a Access Level (Area) in
read or write, permitting users to access commands not only on a hierarchy
scale but also by area of competence.
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OperatingSystemAccess
Movicon provide the possibility to block and deny operating system access. The
follow two modalities can be used:

Lockout Windows access from Movicon: to prevent unauthorized access
in the system you need to select all the project’s Execution Properties
which deny access to the Operating System and Desktop. When
Movicon is started up these will deny access to Windows according to the
settings, which have been activated (described above).
o

Warning! Commencing with Windows Vista/7 Microsoft has
implemented securities which impede the "Ctrl+Alt+Del"
combo keys and the Windows “Start” button from being
disabled.
Using Windows services: you can configure the project to be installed as
the operating system’s Service, therefore it will be started up automatically
before the Windows XP/Vista/7 operating System’s Log On procedure. By
doing this, as an alternative to the above indications, only the system
administrator can access the operating system.
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This is the Project’s control panel. The command, underlined
in red, automatically installs the project as Service.
As explained above, the running of Windows Services differs depending on the
operating system being used. Therefore particular attention must be paid to
graphical interfaces for Windows Services using Windows Vista/7 operating systems
where their use is no longer supported.
BiometricSystems
Using Biometric Systems is highly recommended in application validity according to
the regulations.
In this case you need to choose the right recognition system among those available
on the market that can be easily integrated into your application.
The most popular biometrics systems are ultimately those that use digital
fingerprints. These systems are simple to use and integrate perfectly with operating
systems and software applications.
Examples:
Progea has run tests on the Toca Fkey product (digital fingerprint scanner). This
device can be plugged in to a USB port and has its own user profile management
where the Movicon project users can be associated by using the appropriate VBA
script module provided by Progea. This biometric system can be completely
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integrated into the project using the Movicon “User Password –Fingerprint”
association.

Movicon has also run tests on the Microsoft Fingerprint product, a simple and
reasonably priced device that can be plugged into any USB port with
Windows XP. This system runs its own software as service and provides files
where users are inserted and recognised by their biometrics every time a
password entry request is made. A tool, such as this one, does not require
any project modifications or any particular interfacing or configuration.
However, authentication of the operating system’s users (Windows XP only)
is only allowed when the PC users do not belong to a Domain.
Any type of biometrics recognition system can easily be used if the operating system
has been predisposed to support one as described above, otherwise it can be
integrated into the Movicon application by using the appropriate Basic Script
interface.
Recordingdata(AuditTrailorTracing)
Movicon provides the possibility to trace all the status changes of each variable which
has significant relevance to or influence on the process: Usually all the set-point or
process command changes need to be traced.

Note the difference between the Trace and Data Logger files: The Trace
records each data value change in the appropriate database along with all
the relevant information, while the historical value recordings refer to the
historical logging activity executed by the Data Logger resource.

In certain cases, it is sufficient enough to carry out the following procedures to
sensitive data:
1. Request user identification before accessing to commando
2. Identify user and validate them (password management)
3. The user carries out the changes. The variable (Tag) is traced.
4. The value change is recorded in the appropriate Trace DB, reporting the
date, the previous value, the current one and electronic signature.
All the historical information inherent to each change that took place in the
process can be obtained from the appropriate Trace viewer so it can be easily
traced back to what caused it.
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The Tracing function is one of the properties belonging to each single Variable
(Tag) and must be activated and configured by clicking on the “Trace Options”
property in each Tag (variable).
AuditTrail
In many cases, before the user can proceed in making any process variable changes
(eg. Set points), confirmation may be requested before the change can be put into
action, together with a comment to explain the reason why this change has been
made. (text string). In order to enter this comment the “Trace Comment” item needs
to be ticked/checked in the Trace Property beforehand.
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Movicon will display the window shown above after each manual Tag change occurs
and authenticated by the user, indicating the change and requesting the user to state
the reason this change was made. The comment inserted by the user is recorded:
-
In the ‘ActionCol’ column of the Tracing DB table referring to variable which
was changed.
-
If the ‘Add Msg to SysLog’ check box has been checked, the event and the
comment are also recorded in the main historical Log DB, in the ‘DescCol’ of
the Historical Log’s ‘SysMsgs’ table.
-
Note: When the ‘Trace Comment’ window is open on screen, the variable’s
value will freeze. Any other process, such as the drivers, the IL logic, basic
scripts, will not be able to change it.
AuditTrailwithProcessManagerValidation
There may be times when the above described operations need not only the operator
user’s authentication but also validation from the Process Manager before a Tag
change can be made effective. However, authentication must only be requested
from Process Managers with the same level or higher.
As each process has different needs from the next, Movicon does not manage this
function automatically the user must provide a Template being a graphic object that
can be called up every time an edit request is made. This object allows access, user
identification and data settings (Tag variables), which can be linked to both Tracing
function and a Data Logger which have been configured to record the values relating
to each status change.
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AlarmAcknowledgmentComment(AuditTrail)
In many cases before the user acknowledges an alarm, it may be required to enter a
comment (Audit). When a comment is entered it will be recorded in the historical log
together with the alarm’s ACK event.
The possibility to enter alarm acknowledgement comments can be enabled by
checking the “Comment on ACK (Audit Trail)” option found in the alarm threshold
properties window. When this option is activated and the alarm is acknowledged, a
window will appear showing the information relating to the confirmed alarm and a
space within which the user can enter his/her comments. The edited comments will
then be recorded in the Historical Log’s Alarm table’s “CommCol” column.
Alarms can only be acknowledged after the user has existed from the comment
window with the “OK” button or otherwise cancelled with the ‘Cancel’ button. The
comment window is also managed in network client projects, or when the command
is used in a multi alarm selection, or when using the basic script interface, or with
commands from the command list.
In order to protect alarms from unauthorized users, set a password level in the Alarm
Window so that the user will be required to log on before being able to acknowledge
the alarm in question.
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ElectronicRecords
Electronic Records contain all the process information (dates, values, events)
recorded electronically on files that must guarantee data integrity and prevent any
unlawful handling from unauthorized persons.
All the information recorded on file by Movicon is called “Electronic Records”.
In order to get the Movicon Electronic Records standard ready, the following
indications and the guidelines contained in this document need to be followed to
guarantee security in data integrity and prevention against any unauthourized access
and data tampering.
DataSecurity
Guaranteed Electronic Record security is absolutely fundamental in obtaining valid
applications. The data recorded by Movicoin (Data Loggers, Log, Tracing) are
physically built by:

IMDB: criptable XML text files with an algorithm in 128 bits. To use this
format you need to check the “Cript File” option to guarantee inaccessibility
to external manipulation of historically logged data.

ODBC: Relational Databases by means of the integrated ODBC manager.
The data, therefore, physically resides in data files and tables that can be
recorded on hard disk locally or on mass files residing physically in diverse
servers. Thanks to the use of “safe” relational databases such as SQL Server,
Oracle or others, Movicon uses protected accounts for accessing files. It is
the user’s responsibility to configure the system so that no one can access
files, by removing access rights to file both in the database itself and in the
operating system folders access rights (Movicon run as service). Data security
must be guaranteed by means of using the following procedures:
1. Always use a data format based on relational databases that provide access
protection, such as Microsoft SQL or Oracle.
2. To avoid unauthorized access to files, User Account protection will need to be
setup by using the access criteria explicitly for system administrators or
program designers only (eg. With the same project protection password).
This will impede access to data tables where authorization has not been
provided.
3. Use the operating system’s access lock (Locked by Movicon) or access rights
to operating system by using Movicon as Service. By doing this, file access
through the operating system will be physically denied.
4. Do not share folders or disks when the station is operating in net, except for
system administrator access.
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5. Remove all rights to modify database records (Updates). Movicon lets new
records to be inserted whose data cannot be accessed for altering no matter
what the reason is.
Implementing CFR21 Part 11 with Movicon 11
24
The21CFRPart11.regulations
Tips and suggestions on how to get your Movicon 11 project compliant with the 21
CFR Part 11 regulations.
PART 11—ELECTRONIC RECORDS;
ELECTRONIC SIGNATURES
SubpartA—GeneralProvisions
Sec.
11.1 Scope.
11.2 Implementation.
11.3 Definitions.
SubpartB—ElectronicRecords
11.10 Controls for closed systems.
11.30 Controls for open systems.
11.50 Impiego della firma.
11.70 Collegamenti tra firma e record.
SubpartC—ElectronicSignatures
11.100 General requirements.
11.200 Electronic signature components and
controls.
11.300 Controls for identification
codes/passwords.
Authority: Secs. 201–903 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
321–393); sec. 351 of the Public Health
Service Act (42 U.S.C. 262).
Implementing CFR21 Part 11 with Movicon 11
25
Section
Specification
Subpart A
GeneralProvisions
§ 11.1
Scope
(a) The regulations in this part set forth the criteria under which the
agency considers electronic records, electronic signatures, and handwritten
signatures executed to electronic records to be trustworthy, reliable, and
generally equivalent to paper records and handwritten signatures executed
on paper.
(b) This part applies to records in electronic form that are created,
modified, maintained, archived, retrieved, or transmitted, under any
records requirements set forth in agency regulations. This part also applies
to electronic records submitted to the agency under requirements of the
Federal Food, Drug, and Cosmetic Act and the Public Health Service Act,
even if such records are not specifically identified in agency regulations.
However, this part does not apply to paper records that are, or have been,
transmitted by electronic means.
(c) Where electronic signatures and their associated electronic records
meet the requirements of this part, the agency will consider the electronic
signatures to be equivalent to full handwritten signatures, initials, and
other general signings as required by agency regulations, unless specifically
excepted by regulation(s) effective on or after August 20, 1997.
(d) Electronic records that meet the requirements of this part may be used
in lieu of paper records, in accordance with § 11.2, unless paper records
are specifically required.
(e) Computer systems (including hardware and software), controls, and
attendant documentation maintained under this part shall be readily
available for, and subject to, FDA inspection.
§ 11.2
Implementation.
(a) For records required to be maintained but not submitted to the agency,
persons may use electronic records in lieu of paper records or electronic
signatures in lieu of traditional signatures, in whole or in part, provided that
the requirements of this part are met.
Implementing CFR21 Part 11 with Movicon 11
26
(b) For records submitted to the agency, persons may use electronic
records in lieu of paper records or electronic signatures in lieu of traditional
signatures, in whole or in part, provided that:
(1) The requirements of this part are met; and
(2) The document or parts of a document to be submitted have been
identified in public docket No. 92S–0251 as being the type of submission
the agency accepts in electronic form. This docket will identify specifically
what types of documents or parts of documents are acceptable for
submission in electronic form without paper records and the agency
receiving unit(s) (e.g., specific center, office, division, branch) to which
such submissions may be made. Documents to agency receiving unit(s) not
specified in the public docket will not be considered as official if they are
submitted in electronic form; paper forms of such documents will be
considered as official and must accompany any electronic records.
Persons are expected to consult with the intended agency receiving unit for
details on how (e.g., method of transmission, media, file formats, and
technical protocols) and whether to proceed with the electronic submission.
§ 11.3
Definitions.
(a) The definitions and interpretations of terms contained in section 201 of
the act apply to those terms when used in this part.
(b) The following definitions of terms also apply to this part:
(1) Act means the Federal Food, Drug, and Cosmetic Act (secs. 201–903
(21 U.S.C. 321–393)).
(2) Agency means the Food and Drug Administration.
(3) Biometrics means a method of verifying an individual’s identity based
on measurement of the individual’s physical feature(s) or repeatable
action(s) where those features and/or actions are both unique to that
individual and measurable.
(4) Closed system means an environment in which system access is
controlled by persons who are responsible for the content of electronic
records that are on the system.
(5) Digital signature means an electronic signature based upon
cryptographic methods of originator authentication, computed by using a
set of rules and a set of parameters such that the identity of the signer and
the integrity of the data can be verified.
(6) Electronic record means any combination of text, graphics, data, audio,
Implementing CFR21 Part 11 with Movicon 11
27
pictorial, or other information representation in digital form that is created,
modified, maintained, archived, retrieved, or distributed by a computer
system.
(7) Electronic signature means a computer data compilation of any symbol
or series of symbols executed, adopted, or authorized by an individual to
be the legally binding equivalent of the individual’s handwritten signature.
(8) Handwritten signature means the scripted name or legal mark of an
individual handwritten by that individual and executed or adopted with the
present intention to authenticate a writing in a permanent form. The act of
signing with a writing or marking instrument such as a pen or stylus is
preserved. The scripted name or legal mark, while conventionally applied to
paper, may also be applied to other devices that capture the name or
mark.
(9) Open system means an environment in which system access is not
controlled by persons who are responsible for the content of electronic
records that are on the system.
Implementing CFR21 Part 11 with Movicon 11
28
Section
Subpart B
§ 11.10
Specification
Movicon Solution
ElectronicRecords
Controls for closed systems.
Persons who use closed systems to
create, modify, maintain, or
transmit electronic records shall
employ procedures and controls
designed to ensure the
authenticity, integrity, and, when
appropriate, the confidentiality of
electronic records, and to ensure
that the signer cannot readily
repudiate the signed record as not
genuine. Such procedures and
controls shall include the following:
Movicon users are, alone, responsible
in creating projects according to the
regulations indicated by this act. The
Movicon project must be configured
for correct User Profile management
use by exploiting the security criteria
and unequivocalness of Movicon.
(a)
Validation of systems to ensure
accuracy, reliability, consistent
intended performance, and the
ability to discern invalid or altered
records.
Movicon users must validate their
applications in appliance to the
FDA act. Users can develop
and/or execute the validation of
programs and protocols
themselves or delegate this job to
someone else. Validation should
be done according to the system’s
life cycle (SCL).
(b)
The ability to generate accurate
and complete copies of records in
both human readable and
electronic form suitable for
inspection, review, and copying by
the agency. Persons should
The Movicon application must be
capable of recording data in
electronic format by using a safe
format (crypted IMDB or safe
databases such as SQL Server,
Implementing CFR21 Part 11 with Movicon 11
Procedures must be taken against any
kind of data mishandling by using
IMDB with crypted historical data or
ODBC with Movicon configured as
Windows XP/Vista/7 Service, so that
the operating system’s security
features can be used in their entirety
when accessing recorded data.
29
(c)
contact the agency if there are any
questions regarding the ability of
the agency to perform such review
and copying of the electronic
records.
Oracle...).
Protection of records to enable
their accurate and ready retrieval
throughout the records retention
period.
Records stored by Data Loggers,
Historical Logs or Tracers are
archived in a crypted IMDB or
ODBC with access security to
protect them against undesired or
unauthorised access. The security
against mishandling data stored
in the ODBC can be guaranteed by
using the operating system’s
protection features and by
running Movicon as a Windows
XP/Vista/7 Service, or by using
the protection offered by safe
Relational DBs (SQL Server,
Oracle, etc.) Archived records
must be kept stored for an
adequate period of time (at least
one year). Movicon provides
archives, which can be sized and
automatically recycled as desired
by the programmer with backup
procedures implemented with the
appropriate Movicon functions.
Implementing CFR21 Part 11 with Movicon 11
The records can be recorded by
using the Data Logger, Historical
Log and Tracing resources. All
the historicals track down the
Active User, date, time and reason
why recording took place. The
Movicon Historical Log
automatically records the users
and system events. The records
are recorded in a database where
data can be accessed safely and
reviewed in the same project by
using either the viewers, the
Reports functions or by using the
purposely created Basic Script
procedures.
30
(d)
Limiting system access to
authorized individuals.
The Movicon security functions
and password management must
be used for limiting access to
operations carried out in the
project. Movicon automatically
manages access levels, encrypts
passwords (project encryption),
controls uniqueness and
discourages any unauthorized
access attempts by recording
these events on Log.
Furthermore, Movicon can be
used as Service in the Windows
XP/Vista/7 environment and
shares passwords with the
operating system’s domain.
Both Movicon and the operating
system manage (when enabled)
Auto-Logoff (timeout) so that the
inactive user only remains
enabled in the system for the
limited period of time set before
being automatically logged off.
(e)
(f)
Use of secure, computergenerated, time-stamped audit
trails to independently record the
date and time of operator entries
and actions that create, modify, or
delete electronic records. Record
changes shall not obscure
previously recorded information.
Such audit trail documentation
shall be retained for a period at
least as long as that required for
the subject electronic records and
shall be available for agency
review and copying.
All the records stored on
Database by Movicon must
include the date and time (in PC’s
local time or synchronized GMT
origin) both for Data Loggers and
for recorded events (ODBC
Historical Log). User LogOn and
LogOff events are also recorded.
Use of operational system checks
to enforce permitted sequencing of
The Movicon User is responsible
for applying the necessary
Implementing CFR21 Part 11 with Movicon 11
When more than one station is
being used, Client/Server
architecture, the server must be
made ready to synchronize the
clocks of clients in the system to
get one communal date and time
reference.
31
steps and events, as appropriate.
security procedures to permit the
sequencing of steps and events.
The automatic batch procedure
can be used to manage operations
and recipes in a step-by-step
sequence.
All the set or modified data can be
recorded by using an appropriate
function (Datalogger or Variable
Tracing).
Clients must develop systems
which combine recipes, logic and
security in order to verify whether
all operations are being carried
out correctly.
(g)
Use of authority checks to ensure
that only authorized individuals
can use the system, electronically
sign a record, access the operation
or computer system input or
output device, alter a record, or
perform the operation at hand.
The Movicon security functions
and password management must
be used to limit access to
operations in the project.
Movicon automatically manages
access levels, encrypts passwords
(project encryption), controls
uniqueness and discourages any
unauthorized access attempts by
issuing a warning of this event.
Furthermore, Movicon can be
used as Service in the Windows
XP/Vista/7 environment and
shares passwords with the
operating system’s domain.
Both Movicon and the OS manage
(when enabled) Auto-Logoff
(timeout) so that the inactive
user only remains logged on to
the system for a set limited time
period before being automatically
logged off.
Implementing CFR21 Part 11 with Movicon 11
32
(h)
Use of device (e.g., terminal)
checks to determine, as
appropriate, the validity of the
source of data input or operational
instruction.
To guarantee data source validity,
Movicon projects should be
created with Client/Server
configurations for each
workstation exiting in the system
with all recorded data filed safely
in the Central PC (Server)
redundant and protected against
any kind of mishandling.
(Windows XP/Vista/7 OS and the
used database security).
(i)
Determination that persons who
develop, maintain, or use
electronic record/electronic
signature systems have the
education, training, and
experience to perform their
assigned tasks.
Movicon clients are responsible
for ensuring that all persons
involved with system
management are fully qualified
with the right training and
information and enough
experience to carry out the tasks
assigned to them.
(j)
The establishment of, and
adherence to, written policies that
hold individuals accountable and
responsible for actions initiated
under their electronic signatures,
in order to deter record and
signature falsification.
Movicon clients are responsible
for setting up policies and
procedures to adapt the use of
applications developed in
conformity with the FDA
regulations.
(k)
Use of appropriate controls over
systems documentation including:
The Movicon users must establish
the right procedures to use and
control documentation relating to
the developed application.
The Movicon User’s Manual can be
Implementing CFR21 Part 11 with Movicon 11
33
(1)
Adequate controls over the
distribution of, access to, and use
of documentation for system
operation and maintenance.
referred to whenever necessary
and is available in paper form or
on Cd-Rom in .PDF electronic
format and therefore cannot be
changed in anyway by the client.
Even though Movicon Clients are
not directly responsible for the
contents of this manual they must
however ensure that it is
distributed, accessed and used
correctly.
(2)
Revision and change control
procedures to maintain an audit
trail that documents timesequenced development and
modification of systems
documentation.
Implementing CFR21 Part 11 with Movicon 11
The Movicon user must set up the
right procedures to ensure that
any modifications done to the
documentation relating to the
developed application or platform
are carried out correctly and kept
under complete control. The
Movicon User’s Manual should be
referred to and all modifications
must always be referred to the
right manual version of the
software installed.
34
§ 11.30
Controls for open systems.
Persons who use open systems to
create, modify, maintain, or transmit
electronic records shall employ
procedures and controls designed to
ensure the authenticity, integrity, and,
as appropriate, the confidentiality of
electronic records from the point of
their creation to the point of their
receipt. Such procedures and controls
shall include those identified in §
11.10, as appropriate, and additional
measures such as document
encryption and use of appropriate
digital signature standards to ensure,
as necessary under the circumstances,
record authenticity, integrity, and
confidentiality.
Implementing CFR21 Part 11 with Movicon 11
Movicon clients are
responsible for setting up the
right procedures and functions
supplied by the systems being
used (Movicon, Windows,
SQL) to ensure that the
system is kept in conformity
with the FDA act.
35
§ 11.50
Signature manifestations.
(a)
Signed electronic records shall contain
information associated with the signing
that clearly indicates all of the
following:
(1)
The printed name of the signer;
Movicon has been designed to
include the unique user name
(name of logged on operator) in
all records stored.
Username information must be
inserted whenever requested
when using Data Loggers.
Movicon must be configured to
record the name of the user
logged on (username must be
unique to that individual).
Username uniqueness is
managed by Movicon.
The date and time are
automatically recorded in the
Movicon historical logs. It is
advised to use GMT otherwise
server and client times and
dates must be synchronized and
the chosen format must be
coherent with that of the Data
Loggers.
(2)
The date and time when the signature
was executed;
(3)
All system events are
The meaning (such as review,
approval, responsibility, or authorship) automatically recorded in the
Movicon Historical Log together
associated with the signature.
with the user name and event
type (eg. ACK, RESET, etc) using
Implementing CFR21 Part 11 with Movicon 11
36
ODBC drivers. However, it is
possible to customize event
recording by using the Data
Logger.
(b)
The Items identified in paragraphs
(a)(1), (1)(2), and (a)(3) of this
section shall be subject to the same
controls as for electronic records and
shall be included as part of any human
readable form of the electronic record
(such as electronic display or printout).
Implementing CFR21 Part 11 with Movicon 11
All records should be stored in a
crypted IMDB database or a
relational ODBC with the
necessary security, and must be
kept stored for an adequate
period of time.
Recorded data can be displayed
in the project by using the right
viewer tools or viewed in Report
printouts using the purposely
created Basic Script procedures.
37
§ 11.70
Signature/record linking.
Electronic signatures and handwritten
signatures executed to electronic
records shall be linked to their
respective electronic records to ensure
that the signatures cannot be excised,
copied, or otherwise transferred to
falsify an electronic record by ordinary
means.
Every record stored by the Data
Loggers must include the
unique name of the user
(operator ID) logged on to the
control system and responsible
for the operations carried out at
that moment.
The Movicon security functions
and password management
with user profiles
must be used for limiting access
to operations in certain areas of
the project.
Movicon automatically manages
user profiles with access levels,
password encryption (project
encryption) and controls user ID
authenticity and uniqueness and
discourages unauthourised
access attempts by recording
them on the Log.
In addition to this, Movicon can
be used as Service in the
Windows XP/Vista/7
environment and shares
passwords from the OS domain.
Both Movicon and the OS
manage (when enabled) AutoLogoff (timeout) so that the
inactive user only remains
logged on to the system for a
set limited time period before
being automatically logged off.
Implementing CFR21 Part 11 with Movicon 11
38
Section
Specification
Movicon Solution
Subpart C
ElectronicSignatures
§ 11.100
General Requirements
(a)
Each electronic signature shall be
unique to one individual and shall
not be reused by, or reassigned to,
anyone else.
Each electronic signature used in
the system must be unique to that
individual and not be reused or
reassigned to any other person.
.
The Movicon security
management, like that of the
Windows XP/Vista/7 OS, does not
allow user duplication which
means the same electronic
signature cannot be reused or
reassigned to another individual.
The Movicon User Profiles
(electronic signatures) are
individual and unique to the user
they were originally assigned to.
(b)
Before an organization establishes,
assigns, certifies, or otherwise
sanctions an individual’s electronic
signature, or any element of such
electronic signature, the organization
shall verify the identity of the
individual.
Implementing CFR21 Part 11 with Movicon 11
Movicon users who develop
applications in conformity with
the FDA act are responsible for
carrying out the right security
checks to control and verify the
authenticity of each individual
person before they are assigned
an electronic signature to access
system data.
39
Movicon clients using FDA ready
applications are responsible for
certifying that the electronic
signatures in their system are the
legal equivalent of traditional
handwritten signatures whenever
requested by the FDA agency.
(c)
Persons using electronic signatures
shall, prior to or at the time of such
use, certify to the agency that the
electronic signatures in their system,
used on or after August 20, 1997,
are intended to be the legally
binding equivalent of traditional
handwritten signatures.
(1)
The certification shall be submitted
in paper form and signed with a
traditional handwritten signature, to
the Office of Regional Operations
(HFC–100), 5600 Fishers Lane,
Rockville, MD 20857.
(2)
Persons using electronic signatures
shall, upon agency request, provide
additional certification or testimony
that a specific electronic signature is
the legally binding equivalent of the
signer’s handwritten signature.
§ 11.200
Electronic signature components and controls.
(a)
Electronic signatures that are not
based upon biometrics shall:
Implementing CFR21 Part 11 with Movicon 11
40
(1)
Employ at least two distinct
Both Movicon and Windows
identification components such as an XP/Vista/7 employ a combination
identification code and password.
of User ID and Password
(encrypted with the project) to
identify users. User identify must
be unique to that individual when
recording data. The User Profile
descriptions are unique to each
single user they refer to in
Movicon (Electronic signature).
Movicon can be configured as
Windows XP/Vista/7 Service in
order to use the entire security
features of the OS in accessing
recorded data.
(i)
When an individual executes a series
of signings during a single,
continuous period of controlled
system access, the first signing shall
be executed using all electronic
signature components; subsequent
signings shall be executed using at
least one electronic signature
component that is only executable
by, and designed to be used only by,
the individual.
Before a continuous period of
controlled system access is
allowed to begin, the Movicon
project will request a Log On
procedure with at least two
identification components (User
ID and Password).
The Active User’s Electronic
Signature is recorded when that
user logs on.
Any subsequent signings done
during this period can be recorded
with the User’s ID only.
(ii)
When an individual executes one or
more signings not performed during
a single, continuous period of
controlled system access, each
signing shall be executed using all of
the electronic signature components.
Implementing CFR21 Part 11 with Movicon 11
The Movicon Automatic Log-Off,
with a preset timeout, is used for
limiting the continuous period of
system access. The Movicon User
should use this function for
deactivating any users who are
still inactive in the control system
after a certain period of time.
41
(2)
Be used only by their genuine
owners;
(3)
Be administered and executed to
ensure that attempted use of an
individual’s electronic signature by
anyone other than its genuine owner
requires collaboration of two or
more individuals.
(b)
Electronic signatures based upon
biometrics shall be designed to
ensure that they cannot be used by
anyone other than their genuine
owners.
Implementing CFR21 Part 11 with Movicon 11
The user must administer the
right procedures to ensure that
the identifications of users in non
biometrics identification systems
(eg. badge reader, transponder)
are genuine.
This procedure should include a
control check to require the
collaboration of two or more
individuals to identify a user who
attempts to access data by using
another individual’s electronic
signature and not his/her own
(this is to ensure that a badge, for
instance, is not used
inappropriately by third parties).
It is the user’s responsibility to
use the functions provided by
Movicon or Windows to impose
expiry time periods on passwords
as well as ensuring that only
legitimate owners of passwords
can access (by enabling the “Must
Change Password” or “Expiring
Password (Days)” to impede the
system administrator from
knowing both the User
identification and password of
individual users.
Control Systems can be accessed
by identifications based on
biometrics. Biometric devices are
available on the market and the
Movicon users, developing
applications compatible with the
FDA regulations, or manufacturer
of the installed biometric devices,
are responsible in certifying that
the electronic signatures based on
biometrics are unique and
individual to each user and cannot
be used by any other person not
being the genuine and originally
42
registered user.
Biometic systems can be managed
directly in the Movicon project, by
using the necessary Basic Script
interfaces or managed by the OS
that identifies users and shares
its domain with the Movicon
project users.
§ 11.300 Controls for identification codes/passwords
Persons who use electronic signatures
based upon use of identification codes in
combination with passwords shall
employ controls to ensure their security
and integrity. Such controls shall include:
For a system to meet the
requirements stipulated in these
regulations it must be provided
with access security in the form of
user identifications with a
combination of at least two
components: User ID and
Password.
The user must own an “electronic
signature (Profile description)
that must be unique to that user
in the system.
Movicon also permits OS Domain
sharing.
(a)
Maintaining the uniqueness of each
combined identification code and
password, such that no two individuals
have the same combination of
identification code and password.
Implementing CFR21 Part 11 with Movicon 11
Movicon controls the uniqueness
of each inserted user profile.
Movicon must be configured as a
service in the Windows
XP/Vista/7 environment so that
the OS security functions can be
used in their entirety to ensure
that passwords for accessing data
have controlled longevity and
complete uniqueness.
43
(b)
Ensuring that identification code and
password issuances are periodically
checked, recalled, or revised (e.g., to
cover such events as password aging).
The user is responsible for setting
down the criteria for carrying out
periodical checks and revisions on
passwords or the re-issuing of
expired passwords. Movicon also
permits passwords to have expiry
dates.
Movicon also permits OS Domain
sharing.
(c)
Following loss management procedures
to electronically deauthorize lost, stolen,
missing, or otherwise potentially
compromised tokens, cards, and other
devices that bear or generate
identification code or password
information, and to issue temporary or
permanent replacements using suitable,
rigorous controls.
Movicon Users must create
projects with procedures that
conform to the FDA regulations.
(d)
Use of transaction safeguards to prevent
unauthorized use of passwords and/or
identification codes, and to detect and
report in an immediate and urgent
manner any attempts at their
unauthorized use to the system security
unit, and, as appropriate, to
organizational management.
The Movicon password
management discourages any
unauthorized attempts to access
system data (The response time is
extended on each password entry
attempt which is also by
Windows). Any attempts made
after the 5th failed attempt are
recorded as acts of system
violation.
(e)
Initial and periodic testing of devices,
such as tokens or cards, that bear or
generate identification code or password
information to ensure that they function
properly and have not been altered in an
unauthorized manner.
Movicon Users are responsible for
adopting the right procedures to
ensure that system biometrics
and access management work
correctly and are not tampered
with or mishandled in any way.
Implementing CFR21 Part 11 with Movicon 11
44
This document has been developed by:
Progea Support Team
Modena, Italy
Dated: 20 February 2002
Revision: 6 March 2012 (for Movicon 11)
Specification FDA CFR 21 Part 11 by:
William B. Schultz,
Food And Drug Administration
Deputy Commissioner for Policy.
Dated: March 11, 1997.
Implementing CFR21 Part 11 with Movicon 11
45
Copyrights:
© Progea Srl 2012 All Rights reserved
Movicon is a trademark of Progea Srl
Windows, SQL Server are trademarks of Microsoft inc.
Oracle is a trademark of Oracle inc.
Any other brands or names are property of their respective holders.
This document is subject to change without prior notice.
Implementing CFR21 Part 11 with Movicon 11
46